Expansion of Indication of TAVI -- "Off-Label" vs "On-Label"
Expansion of Indication of TAVI -- "Off-Label" vs "On-Label"
TAVI is a treatment option for surgically high-risk patients. The present study describes the feasibility and outcomes in patients treated in an off-label setting compared with a standard on-label TAVI population. Patients within the off-label group had higher surgical risk (log EuroSCORE: 33 ± 21% in group B vs 22 ± 14% in group A; P<.001). Corresponding to the higher surgical risk, 30-day mortality was higher for off-label treated patients (14.7% in group B vs 7.8% in group A; P=.01).
Nevertheless, the higher mortality and lower device success rates warrant further investigation in a larger number of patients, especially in those with very low EF, severe AR, or anatomical observations considered to be contraindications. However, patients treated as ViV had the lowest 30-day mortality rate (3.3%), emphasizing its great potential as opposed to redo open-heart surgery. Last but not least, the data suggest that TAVI can be used in patients with cardiogenic shock as a safe alternative to SAVR.
Conclusion
TAVI is a treatment option for surgically high-risk patients. The present study describes the feasibility and outcomes in patients treated in an off-label setting compared with a standard on-label TAVI population. Patients within the off-label group had higher surgical risk (log EuroSCORE: 33 ± 21% in group B vs 22 ± 14% in group A; P<.001). Corresponding to the higher surgical risk, 30-day mortality was higher for off-label treated patients (14.7% in group B vs 7.8% in group A; P=.01).
Nevertheless, the higher mortality and lower device success rates warrant further investigation in a larger number of patients, especially in those with very low EF, severe AR, or anatomical observations considered to be contraindications. However, patients treated as ViV had the lowest 30-day mortality rate (3.3%), emphasizing its great potential as opposed to redo open-heart surgery. Last but not least, the data suggest that TAVI can be used in patients with cardiogenic shock as a safe alternative to SAVR.
